FDA to Congress: Double Fees from Device Makers

WASHINGTON -- The doubling of user fees collected from device makers will improve the efficiency of FDA approvals, the agency's head of medical devices told a congressional panel.

Jeffery Shuren, MD, the head of the FDA's Centers for Devices and Radiological Health (CDRH), said that the $595 million in user fees that the FDA will collect from device makers from 2013 to 2017 -- pending congressional approval -- will allow the agency to hire 208 new full-time staff members, which will lead to shorter wait-times for FDA approval of new devices.

The House Energy and Commerce Health Subcommittee hearing met Wednesday to discuss the Medical Device User Fee Act (MDUFA), which was sent to Congress earlier this month. It represents an agreement reached by FDA and the device industry and would more than double the current user fee level of $287 million.

MDUFA was first passed in 2002 and must be reauthorized every five years. Congress has until the end of September to reauthorize the law for the second time.

Shuren told the panel that it should have final language on the agreement in March, at which point the committee would have to turn the proposed wording for the act into an actual bill, approve it, and send it to the House for a full vote. It also would have to be passed by the Senate.

Under the MDUFA proposal, a device company would have to pay about $220,000 to have its high-risk device reviewed under the FDA's premarket review process. Small device makers would be required to pay about $55,000 for a review of a new device. Review of low-risk devices (which are approved through a less stringent process called the 510(k) process) would be much cheaper -- ranging from about $2,000 to $4,000, depending on the size of the device company.

Republicans on the panel seemed hesitant to give the FDA more money without proof that the device industry would see faster approvals with the user fee cash infusion to CDRH.

"To have a proposal put forward to double the user fee with the [current] performance [of the FDA], or lack thereof, is not something I condone," said Joe Barton (R-Texas).

But Shuren told the panel that increased user fees do result in more efficient approvals, pointing to the 106 brand-new devices, as well as 13,000 devices that were similar to something already on the market, that were approved since the last reauthorization of MDUFA in 2007, which also increased user fees.

"There are problems with the program that we can't solve without increased funding," Shuren said, referring to having too few managers in charge of device approval and CDRH's notoriously high staff turnover.

Shuren has said in the past that he would like to hire highly qualified device reviewers but doesn't have the resources to attract seasoned doctors, for instance.

Republicans on the panel also echoed the criticisms of the device industry: That the FDA takes too long to review devices and the process is unpredictable, and as a result companies are launching devices first in foreign countries, and some companies are relocating overseas.

However, on the other side of the issue, consumer groups say the FDA needs to make its approval process more strict because it has allowed approval of dangerous devices. "Congress ... should insist that standards be strengthened and that the FDA step up its efforts to remove demonstrably dangerous devices from the market," Negah Mouzoon, researcher with Public Citizen's Congress Watch group, said in a statement announcing the release of the group's report on the device approval process.

Th FDA paid $1.3 million for the Institute of Medicine (IOM) to study the device review process. The IOM determined that the FDA's 510(k) fast-track approval process for medical devices does not ensure safety and effectiveness and that the FDA should not devote valuable resources to fixing the process.

Shuren said he disagreed with that finding.

"Did you get your money back for that report?" quipped Rep. John Shimkus (R-Ill.).

Detractors of the FDA point to the European Union (EU), where some devices earn approval years before the FDA approves them, if it approves them at all. (Devices in Europe do not have to shown to be effective before approval, they only must be proven safe).

In a paper published Wednesday in the New England Journal of Medicine, researchers led by David Kramer, MD, of Harvard Medical School, compared how devices are approved in the U.S. and the EU and questioned whether the EU's speedier method of approving new technologies improves public health any more than the FDA's "more deliberative posture."

"Certainly, swifter approval helps generate revenue for manufacturers, and physicians may benefit from having more tools at their disposal," the researchers wrote in their study, which was funded in part by a grant from CDRH. "But the primary goal of bringing new devices to market should be to improve the treatment of specific diseases, and no current studies address this outcome."

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